Immune Monitoring Unit

During trial design, IMU can advise on relevant sampling time points and the types of biomaterials (e.g. serum vs. plasma) needed for planned immune assays.

Based on the goals of your study, we can help to select relevant analytical methods.

IMU offers broad assay portfolio, ranging from standard immune monitoring assays such as ELISpot, ELISA, FACS and Luminex to sequening-based methods focused on analysis of adaptive immune repertoires (AIR-Seq). 

For optimal results across patient cohorts, we take great care to assess assay sensitivity and reproducibility. 

Depending on trial needs, we are happy to establish or implement new assays.

→ Learn more about IMMUNE ASSAYS

As part of our QUALITY MANAGEMENT system, all IMU assays adhere to standardized procedures. For an external assessment of our performance, IMU regularly participates in proficiency panels.

Depending on trial needs, assays can be performed in a GCLP-compliant fashion.

While preparing the analytical study plan, immune response and positivity criteria will be defined for each assay. 

We will analyze and summarize immune assay data and provide it in the formats required by differenty stake-holders, such as data-management, study-PI, translational researcher or bioinformatician. 

Raw data will be stored at IMU and can be made available for further analysis.

We can create written reports on our results, including data visualization. 

See PUBLICATIONS with IMU contribution

IMU is experienced in prossessing human blood and tissue samples for various down-stream assays. 

Based on the planned analysis, we will compile an analytical study plan as well as a laboratory manual covering all aspects of sample processing, shipment, storage and logistics.

To ensure standardized sample processing, we organize sample processing at external sites according to our standard operating procedures (SOPs).

All biosamples can be collected and stored at IMU, where we keep records on each sample aliquot. 

→ Learn more about SAMPLE TYPES

Sample quality is the key to reliable results. To ensure consistent sample quality in multi-centric trials, we can train external labs in sample processing procedures.

IMU has established a constantly expanding bank of EBV-transformed B lymphoblastoid cell lines (B-LCLs). All LCL lines have been HLA-typed and thus represent a great source of antigen-presenting cells for various assays.

Please note that handling of EBV-transformed LCLs falls under the German infection protection law (Infektionsschutzgesetz) and can only be performed by holders of an adequate permission.

The trial will address safety and tolerability of the combination of the IDH1R132H-specific vaccine with checkpoint blockade and seeks to explore predictive biomarkers for response to checkpoint blockade in post-treatment tumor tissue. 

Contribution of IMU: Tumor, PBMC, serum and plasma processing for IFNᵞ-ELISpot assays and anti-IDHR132H-ELISA as part of the secondary endpoint analysis; cytokine screening, flow cytometric profiling of immune cell subsets and TCR repertoire analysis for evaluation of explorative endpoints and translational research. Coordination of sample logistics and distribution.

Status: recruitment closed

NK-92/5.28.z consists of NK92 cells modified to express a Her2-neu targeting chimeric antigen receptor (CAR). The objective of this clinical study is to evaluate the safety and tolerability of intracranial injection of NK-92/5.28.z and to determine the maximum tolerated dose or maximum feasible dose (MFD). 

Contribution of IMU: CSF and tumor processing, bulk and single-cell AIR-Seq.

Status: open

The trial will assess save dosing of CVGBM mRNA vaccine in patients who had surgery for glioblastoma or astrocytoma.

Contribution of IMU: PBMC and serum processing

Status: open

AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in 2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group B. 

Contribution of IMU: PBMC, serum and plasma isolation, IFNγ-ELISpot Assay, FACS of checkpoint Inhibitory molecules, Luminex and TCR sequencing as part of the accompanying translational research.

status: recruitment closed 

The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, high PD-L1 mRNA expression or focal MYC(N) amplification and explore activity in biomarker low tumors (low mutational load, low PD-L1 mRNA expression and non-MYC(N) amplified)

Contribution of IMU: PBMC, serum and plasma isolation, flow cytometric analysis of immune biomarkers in fresh blood samples, multiplexed cytokine profiling, coordination of sample logistics and distribution.

status: recruiting

The INTERCEPT H3 trial combines H3K27M peptide vaccination with radiotherapy and checkpoint inhibitor treatment in patients with diffuse midline gliomas.

Contribution of IMU: Coordination of sample logisitics and collection, training of external labs, processing of PBMC, serum, plasma, CSF and tumor for immune assays, including IFNγ ELISpot assays for immunogenicity assessment (primary endpoint), flow-cytometry, ELISA and TCR repertoire analysis for secondary endpoints and translational research.

 status: open

This trial makes use of a patient-individual salmonella Ty21a carrier-based DNA plasmid vaccine that can be orally administered and enrolls patients of different tumor entities.

Contribution of IMU: Training of external labs, logistic of PBMC collection, evaluation of antigen-specific T cell responses.

status: open

This trial makes use of a patient-individual salmonella Ty21a carrier-based DNA plasmid vaccine that can be orally administered. NECVAX-NEO1-02-INT enrolls patients with solid tumors who also receive standard-of-care treatment with PD-1 or PD-L1 monoclonal antibody inhibitor therapy. 

Contribution of IMU: Training of external labs, logistic of PBMC collection, PBMC isolation, evaluation of antigen-specific T cell responses.

status: open

This trial makes use of a patient-individual salmonella Ty21a carrier-based DNA plasmid vaccine that can be orally administered and enrolls patients with newly diagnosed breast cancer. The vaccine is administered parallel to chemotherapy and an immunostimulatory antibody prior to surgical tumor resection, with optional prolongation of treatment after surgery.

Contribution of IMU: Training of external labs, logistic of PBMC collection, PBMC isolation, evaluation of antigen-specific T cell responses.

status: open

The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1) peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to glutamine at position 132 of IDH1). The aim of this trial is to evaluate the safety and tolerability of and immune response to the IDH1 peptide vaccine in patients with IDH1R132H-mutated, WHO grade III-IV gliomas.

Contribution of IMU: PBMC, serum and plasma processing for and IFNγ-ELISpot assay and IDH1R132H antibody response via ELISA as part of the primary endpoint analysis.

see Platten et al., Nature 2021 (https://pubmed.ncbi.nlm.nih.gov/33762734/) for results.

A multicenter phase I/II trial to evaluate the efficacy and safety combining oral T cell vaccination targeting VEGRF2 (VXM01) with anti-PD-L1 checkpoint inhibitor therapy (Avelumab) in recurrent Glioblastoma patients following tumor resection and radiochemotherapy containing temozolomide.

Contribution of IMU: Processing of PBMC, and tissue samples as part of the exploratory endpoint analysis. IFN-γ ELIspot, flow cytometry Immunophenotyping and TCR repertoire profiling to monitor vaccine induced T cell responses.

status: closed